PD03-01: BCG vs chemohyperthermia with mitomycin C for high-risk non-muscle invasive bladder carcinoma: preliminary results of HIVEC-HR randomized clinical trial

Felix Guerrero-Ramos, Daniel Antonio Gonzalez-Padilla, Alejandro Gonzalez-Diaz, Felipe Villacampa-Auba, Marta Rodriguez-Izquierdo, Carmen Gomez-Cañizo, Federico de la Rosa-Kehrmann, Alfredo Rodriguez-Antolin

Introduction: There is an increasing interest in finding a valid alternative for patients with non-muscle invasive bladder cancer (NMIBC). HIVEC-HR is a pilot trial that aims to compare efficacy and safety between BCG and chemohyperthermia (CHT) with mitomycin C (MMC). Here we present our preliminary results once randomization has been completed.

Methods: Open pilot randomized clinical trial 1:1 including patients with high-risk NMIBC according to EAU Guidelines (EudraCT 2016-001186-85). Patients with CIS, intolerance or contraindication for receiving BCG or MMC were excluded.

Patients were randomly assigned to one of the following groups:

- BCG (TICE strain): 50 mg diluted in 50 mL of sterile saline held for 2 hours in the bladder, one weekly instillation for 6 weeks and maintenance according to SWOG protocol.
- CHT: 40 mg MMC diluted in 40 mL of distilled water at 43ºC using COMBAT® recirculation system for 60 minutes, one weekly instillation for 6 weeks and one monthly instillation for 6 months.

Follow-up was performed with cytology+cystoscopy every 3 months as well as upper urinary tract imaging yearly, as stated by EAU Guidelines.

Primary endpoint was recurrence-free survival at 24 months. Secondary objectives: safety, progression rate, overall survival and quality of life.

Results: Fifty patients randomized (100% recruitment completed), 48 finally starting treatment. Median age is 73 years, 87.6% males and 83% primary tumours. Baseline characteristics were comparable in both groups. Median follow-up is 24.8 months from TURBT.

For the BCG group, 6 recurrences (from which 5 progressions to T2) were reported, and only 3 recurrences (from which 2 progressions) happened in the CHT group.

Regarding safety profile, adverse events (AE) appeared in 12 patients from CHT and 10 from BCG group, with no differences in the severity (4 patients in each group for CTCAE grade 3). AE in CHT group were mostly grade 1.

Conclusions: According to our trial preliminary results, CHT in high risk NMIBC patients seems at least not to be inferior to BCG in terms of efficacy. Moreover, patients under CHT have milder side effects than those under BCG treatment. Source of

Funding: None.